cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lot numbers
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Roche Molecular Systems, Inc.
- Reason for Recall:
- False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Product Codes/Lot Numbers:
All lot numbers
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0083-2022
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